A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel on Ablation of Upper Urinary Tract Urothelial Carcinoma
Hristos Kaimakliotis, MD
Primary Investigator
Brief description of study
The study is investigating the ability of UroGen's MitoGel procedure to treat urothelial carcinoma tumors from the upper urinary tract.
Detailed description of study
The purpose of this study is to assess the efficacy, safety, and tolerability of treatment with MitoGel instilled in the upper urinary system of patients with non-invasive low-grade (LG), UTUC.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Upper Tract Urothelial Carcinoma,Urinary Tract Urothelial Carcinoma
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system
Patient has at least one (1) measurable and biopsy-confirmed papillary LG tumor, evaluated visually, less than or equal to 15 mm. The largest lesion should not exceed 15mm.
Following biopsy patient should have at least one remaining lesion with a diameter of 5 mm.
Patient with bilateral LG UTUC may be enrolled if at least one side meets the inclusion criteria for the trial and if the other kidney does not require further treatments (The other kidney can be treated prior to the beginning of the study)
Exclusion Criteria
Patient received BCG treatment for UC during the 6 months prior to Visit 1
The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
CIS in the past in the urinary tract
Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years
Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years
Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial
